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Nanoparticle Albumin-Bound (Nab) Paclitaxel/Cyclophosphamide in Early-Stage Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00629499
Recruitment Status : Completed
First Posted : March 6, 2008
Results First Posted : December 20, 2012
Last Update Posted : November 24, 2021
Celgene Corporation
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Brief Summary:
This is a non-randomized, Phase II study. Efficacy is not a primary endpoint in this study; however, progression-free survival will be followed and determined for the patients in this study. Approximately 50 patients are planned to be enrolled in this study.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: nab paclitaxel Drug: Cyclophosphamide Drug: Trastuzumab Phase 2

Detailed Description:

Given the favorable activity demonstrated in a trial using the taxane docetaxel in combination with cyclophosphamide, we propose a Phase II trial of 4 cycles of weekly nab paclitaxel combined with cyclophosphamide. The favorable toxicity profile for weekly nab paclitaxel, in addition to its demonstrated superiority over standard paclitaxel in early-stage breast cancer, makes it an ideal taxane to evaluate in this setting. In this study, nab paclitaxel will be administered once weekly, in combination with q3wk cyclophosphamide. By using this combination therapy method, the goal of this study is to maximize the opportunity to demonstrate improved tolerability of adjuvant nab paclitaxel using a weekly dosing schedule in combination with q3wk cyclophosphamide.

In this study, patients who demonstrate FISH or IHC3+ HER2 positivity and adequate cardiac function will also receive treatment with trastuzumab in addition to the nab paclitaxel / cyclophosphamide combination therapy. Trastuzumab will be administered IV using an 8 mg/kg loading dose on Day 1 of the treatment period. If no toxicity occurs, subsequent doses of trastuzumab will be administered IV as a 6 mg/kg dose approximately every 21 days for a total of 52 weeks (thus, maintenance therapy with trastuzumab will continue after the 12-week period of combination therapy with nab paclitaxel/cyclophosphamide/trastuzumab has ended).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Nanoparticle Albumin-Bound (Nab) Paclitaxel/Cyclophosphamide in Early-Stage Breast Cancer (With Trastuzumab in HER2 Positive Patients)
Study Start Date : April 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Intervention
100 mg/m2 of intravenous (IV) nab paclitaxel weekly (i.e., on Days 1, 8, and 15 of each 3 week treatment cycle) in combination with 600 mg/m2 of IV cyclophosphamide once every 3 weeks for 4 cycles (i.e., a total treatment period of 12 weeks [84 days]). Patients with fluorescence in situ hybridization (FISH) HER2+ or IHC3+ breast cancer will also receive treatment with trastuzumab in addition to the nab paclitaxel / cyclophosphamide combination therapy. Maintenance therapy with trastuzumab will continue (for the HER2+ patients who are receiving trastuzumab) after the 12-week treatment period with combination nab paclitaxel/cyclophosphamide/trastuzumab. The total treatment time for trastuzumab will be 52 weeks rather than only 12 weeks.
Drug: nab paclitaxel
100 mg/m2 of intravenous (IV) nab paclitaxel weekly (i.e., on Days 1, 8, and 15 of each 3 week treatment cycle)
Other Name: Abraxane

Drug: Cyclophosphamide
600 mg/m2 of IV cyclophosphamide
Other Name: Cytoxan

Drug: Trastuzumab
8 mg/kg loading dose of IV trastuzumab will be administered on Day 1, followed by doses of 6 mg/kg IV trastuzumab once every 3 weeks.
Other Name: Herceptin

Primary Outcome Measures :
  1. Number of Participants Who Remained Alive Without Evidence of Recurrence as a Measure of Tolerability of Adjuvant Nab Paclitaxel [ Time Frame: 18 Months ]

Secondary Outcome Measures :
  1. Disease-free Survival [ Time Frame: 18 Months ]
    Number of participants that are disease free at 18th month

  2. Overall Survival [ Time Frame: 18 Months ]
    Number of participants that are alive at 18th month

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed invasive adenocarcinoma of the breast or inflammatory breast cancer, with an interval between definitive breast surgery and study registration of <60 days.
  • Definitive surgical treatment must be either mastectomy or breast-conserving therapy with axillary lymph node dissection for operable breast cancer (pT1 4 [including inflammatory breast cancer], pN0 3, and M0). Margins of resected specimen from definitive surgery must be histologically free of invasive adenocarcinoma and ductal carcinoma in situ (DCIS). Lobular carcinoma in-situ does not count as a positive margin.
  • Patients with ≥1 axillary lymph node containing metastatic adenocarcinoma measuring >0.2 mm, OR lymph node-negative patients with high-risk features
  • Patients with HER2/neu positive or negative tumors (HER2 positivity must be documented by FISH positivity or IHC 3+).
  • Patients who are to receive trastuzumab must have normal cardiac function (MUGA [cardiac ejection fraction >50%, or greater than or equal to the institutional lower limit of normal], or echocardiogram [ECHO] within institutional normal limits).
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2.
  • Patients who are either chemotherapy naïve, or who have received prior chemotherapy >5 years ago.
  • Patients with previous invasive cancers (including breast cancer) eligible only if treated >5 years prior to entering this study, and show no evidence of recurrent disease.
  • Adequate bone marrow function
  • Adequate liver function,
  • Adequate renal function,
  • Patients of childbearing potential must use an effective method of contraception that is acceptable to their study physician from the time of signing informed consent until at least 3 months after the last dose of protocol treatment, and must have a negative pre study serum pregnancy test.
  • Pre-existing peripheral neuropathy must be less than or equal to grade 1 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 criteria.
  • MammoSite® brachytherapy radiation accepted when performed immediately following surgery and prior to receiving chemotherapy.
  • Patients with bilateral, synchronous breast cancer, provided that one primary tumor meets the inclusion criteria.

Exclusion Criteria:

  • Patients who are pregnant or breastfeeding.
  • M1 metastatic disease.
  • Patients requiring neoadjuvant chemotherapy.
  • Life expectancy of greater than 6 months.
  • History of cardiac disease, with a New York Heart Association (NYHA) Class II or greater CHF
  • Myocardial infarction (MI) or unstable angina in the past 12 months prior to Day 1 of treatment, serious arrhythmias requiring medication for treatment, any history of stroke or transient ischemic attack at any time, clinically significant peripheral vascular disease, or evidence of a bleeding diathesis or coagulopathy.
  • Any investigational agent within 30 days of receiving the first dose of study drug.
  • Treatment with prior trastuzumab or bevacizumab therapy.
  • Concurrent treatment with any other anti-cancer therapy is not permitted.
  • History of significant psychiatric disorders.
  • History of active, uncontrolled infection.
  • A serious, non-healing wound, ulcer, or bone fracture.
  • Any other diseases, metabolic dysfunction, findings from a physical examination, or clinical laboratory test results that give reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results or that renders the patient at high risk from treatment complications.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00629499

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United States, Florida
Watson Clinic Center for Cancer Care and Research
Lakeland, Florida, United States, 33805
Gulfcoast Oncology Associates
Saint Petersburg, Florida, United States, 33705
United States, Kentucky
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States, 40207
United States, Maine
Mercy Hospital
Portland, Maine, United States, 04101
United States, Maryland
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817
United States, Michigan
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States, 49503
United States, Missouri
St. Louis Cancer Care
Chesterfield, Missouri, United States, 63017
United States, North Carolina
Cancer Care of Western North Carolina
Asheville, North Carolina, United States, 28801
United States, Tennessee
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023
United States, Virginia
Peninsula Cancer Institute
Newport News, Virginia, United States, 23601
Sponsors and Collaborators
SCRI Development Innovations, LLC
Celgene Corporation
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Study Chair: John Hainsworth, MD SCRI Development Innovations, LLC
Additional Information:
PubMed  This link exits the site

Publications of Results:
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Responsible Party: SCRI Development Innovations, LLC Identifier: NCT00629499    
Other Study ID Numbers: SCRI BRE 116
First Posted: March 6, 2008    Key Record Dates
Results First Posted: December 20, 2012
Last Update Posted: November 24, 2021
Last Verified: November 2021
Keywords provided by SCRI Development Innovations, LLC:
Early Stage Breast Cancer
nab paclitaxel
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological